INDICATION:

LONSURF® (trifluridine and tipiracil) tablets are indicated for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild type, an anti-EGFR therapy.

Staying connected
to your needs.

Accessing treatments can be challenging at times. Taiho Oncology Patient Support™ offers personalized services to give patients, caregivers and healthcare professionals (HCPs) the help they need in getting started with LONSURF® (trifluridine and tipiracil) tablets. This includes insurance verification, help with medication costs, and treatment plan support.

Why enroll in the Taiho Oncology Patient Support™ Program?

For HCPs,
the program:

  • Offers a secure, easy-to-use online provider portal that stores patients' info and tracks insurance details, prescription history and more
  • Simplifies patient access to LONSURF by providing insurance coverage support, prescription coordination and financial help for eligible patients
  • Makes enrolling patients simple with options to submit electronically or by fax

For LONSURF patients,
the program:

  • Makes getting your prescribed treatment as easy as possible by helping you fulfill insurance requirements and coordinating your prescription
  • Offers financial assistance* in various ways based on your current coverage
  • Gives you 24/7 personalized nurse support† by phone upon request, to help you stay on track with LONSURF
  • Starts with an easy-to-complete Enrollment Form you can bring to your doctor
*Based on eligibility and additional criteria.
†If selected on the Patient Enrollment Form, a Nurse Navigator will be assigned to provide telephone support and will address general inquiries about LONSURF treatment.

Hear more about Taiho Oncology Patient Support

Watch Tim Whitten, President and Chief Executive Officer of Taiho Oncology, Inc., introduce the services offered through the program.

Access Support

The Taiho Oncology Patient Support Program simplifies access for those who have been prescribed LONSURF as part of their treatment. Just a phone call away, we can help determine insurance coverage, coordinate prescriptions, and more.

Access and reimbursement support includes:

  • Helping patients understand their insurance coverage and/or out-of-pocket responsibility through Benefit Verifications (BVs)
  • Determining prior authorization requirements of the insurance company
  • Assisting with appeals if coverage is denied

Pharmacy
coordination
includes:

  • Triaging patients' prescriptions
  • Coordinating prescriptions with the specialty pharmacy, self-dispensing practice, or hospital outpatient pharmacy
  • Communicating regularly with patients about prescription status

Financial Support

For those who have difficulty affording LONSURF, the Taiho Oncology Patient Support Program can help identify options for financial support.

For private- or
commercially-
insured patients

  • Taiho Oncology Patient Support Co-pay Card reduces out-of-pocket costs for those who are eligible

For public- or
government-
insured patients
(eg. Medicare, Medicaid)

  • Extra Help, the Low-Income Subsidy (LIS) from Medicare program, provides financial assistance for patients who may otherwise be unable to afford the costs associated with their Medicare Part D plan (to learn more, click here)
  • Referrals to non-profit foundations for co‑pay or other assistance‡
  • A Patient Assistance Program that provides financial assistance for eligible patients who have insufficient insurance coverage and insufficient financial resources to pay for treatment
  • May arrange for patients to receive LONSURF at no cost based on assistance, financial, and medical criteria

For underinsured or
uninsured patients

  • A Patient Assistance Program that provides financial assistance for eligible patients who have insufficient or no prescription insurance
  • May arrange for patients to receive LONSURF at no cost based on assistance, financial, and medical criteria
‡Taiho Oncology does not influence or control the decisions of these co-pay assistance foundations, but Taiho Oncology Patient Support can assist patients by making an appropriate referral based on a patient's diagnosis. Each co-pay assistance foundation has its own criteria for patient eligibility. We cannot guarantee financial assistance once a patient has been referred.

How To Enroll

We offer 3 convenient ways to enroll to help simplify treatment access.

You can enroll in the Taiho Oncology Patient Support Program:

BY FAX

Patient and HCP complete and sign a Patient Enrollment Form and then fax it to 1‑844‑287‑2559.

ONLINE

Patient completes a Patient Enrollment Form online and brings it to the HCP's office, or HCP completes it electronically.

BY PHONE

1‑844‑TAIHO‑4U
(1‑844‑824‑4648) for help with enrollment.

Once enrolled, HCPs can expect one of our Taiho Oncology Patient Support Reimbursement Specialists to:

  • Confirm patient enrollment and share next steps
  • Create the patient's account and ensure accuracy of information
  • Facilitate services selected on the Patient Enrollment Form
  • Triage patient's prescription and coordinate with the dispensing specialty pharmacy once LONSURF coverage has been verified
  • Coordinate follow-up, reminders, and personalized nurse support upon request

Once enrolled, patients can expect Taiho Oncology Patient Support to:

  • Welcome them to the Program and explain their insurance benefits for LONSURF
  • Confirm access to LONSURF via insurance coverage or assist in applying for financial assistance
  • Coordinate with the specialty pharmacy to discuss payment and, if applicable, shipment
  • Support them after they receive LONSURF from the specialty pharmacy, physician, or hospital and begin treatment

Resources

Patient Starter Kit

Along with our Patient Support Program, Taiho Oncology is pleased to offer a Patient Starter Kit containing useful resources to help inform patients and caregivers about all aspects of LONSURF — including how it works, how it may help, potential side effects, and dosage information. The Kit contains a:

  • Welcome Letter
  • LONSURF Treatment Companion
  • LONSURF Caregiver Brochure
  • Treatment Calendar
  • Pill Boxes
  • Thermometer
To request a Patient Starter Kit, please call 1‑844‑TAIHO‑4U (1-844-824-4648)

Online Resources and Tools

We also offer a variety of other downloadable resources and tools.

LONSURF Information for Patients/Caregivers:

LONSURF resources Financial Support Information for Patients

Resources for Physicians:

LONSURF resources
Indication and Important Safety Information +

INDICATION:

LONSURF® (trifluridine and tipiracil) tablets are indicated for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild type, an anti-EGFR therapy.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Severe Myelosuppression: In Study 1, LONSURF caused severe and life‑threatening myelosuppression (Grade 3‑4) consisting of anemia (18%), neutropenia (38%), thrombocytopenia (5%), and febrile neutropenia (3.8%). One patient (0.2%) died due to neutropenic infection. In Study 1, 9.4% of LONSURF‑treated patients received granulocyte‑colony stimulating factors.

Obtain complete blood counts prior to and on day 15 of each cycle of LONSURF and more frequently as clinically indicated. Withhold LONSURF for febrile neutropenia, Grade 4 neutropenia, or platelets less than 50,000/mm3. Upon recovery, resume LONSURF at a reduced dose as clinically indicated.

Embryo‑Fetal Toxicity: LONSURF can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with LONSURF.

USE IN SPECIFIC POPULATIONS

Lactation: It is not known whether LONSURF or its metabolites are present in human milk. There are no data to assess the effects of LONSURF or its metabolites on the breast‑fed infant or the effects on milk production. Because of the potential for serious adverse reactions in breast‑fed infants, advise women not to breastfeed during treatment with LONSURF and for 1 day following the final dose.

Male Contraception: Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use condoms during treatment with LONSURF and for at least 3 months after the final dose.

Geriatric Use: Patients 65 years of age or over who received LONSURF had a higher incidence of the following compared to patients younger than 65 years: Grade 3 or 4 neutropenia (48% vs 30%), Grade 3 anemia (26% vs 12%), and Grade 3 or 4 thrombocytopenia (9% vs 2%).

Hepatic Impairment: Patients with severe hepatic impairment (total bilirubin greater than 3 times ULN and any AST) were not studied. No adjustment to the starting dose of LONSURF is recommended for patients with mild hepatic impairment. Do not initiate LONSURF in patients with baseline moderate or severe (total bilirubin greater than 1.5 times ULN and any AST) hepatic impairment.

Renal Impairment: In Study 1, patients with moderate renal impairment (CLcr=30 to 59 mL/min, n=47) had a higher incidence (difference of at least 5%) of ≥Grade 3 adverse events, serious adverse events, and dose delays and reductions compared to patients with normal renal function (CLcr ≥90 mL/min, n=306) or patients with mild renal impairment (CLcr=60 to 89 mL/min, n=178).

Patients with moderate renal impairment may require dose modifications for increased toxicity. Patients with severe renal impairment were not studied.

ADVERSE REACTIONS

Most Common Adverse Drug Reactions in Patients Treated With LONSURF (≥5%): The most common adverse drug reactions in LONSURF‑treated patients vs placebo‑treated patients with refractory mCRC, respectively, were asthenia/fatigue (52% vs 35%), nausea (48% vs 24%), decreased appetite (39% vs 29%), diarrhea (32% vs 12%), vomiting (28% vs 14%), abdominal pain (21% vs 18%), pyrexia (19% vs 14%), stomatitis (8% vs 6%), dysgeusia (7% vs 2%), and alopecia (7% vs 1%).

Additional Important Adverse Drug Reactions: The following occurred more frequently in LONSURF‑treated patients compared to placebo: infections (27% vs 15%) and pulmonary emboli (2% vs 0%).

The most commonly reported infections which occurred more frequently in LONSURF‑treated patients were nasopharyngitis (4% vs 2%) and urinary tract infections (4% vs 2%).

Interstitial lung disease (0.2%), including fatalities, has been reported in clinical studies and clinical practice settings in Asia.

Laboratory Test Abnormalities in Patients Treated With LONSURF: Laboratory test abnormalities in LONSURF‑treated patients vs placebo-treated patients with refractory mCRC, respectively, were anemia (77% vs 33%), neutropenia (67% vs 1%), and thrombocytopenia (42% vs 8%).

Please see full Prescribing Information.

Indication and Important Safety Information

INDICATION:

LONSURF® (trifluridine and tipiracil) tablets are indicated for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild type, an anti-EGFR therapy.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Severe Myelosuppression: In Study 1, LONSURF caused severe and life‑threatening myelosuppression (Grade 3‑4) consisting of anemia (18%), neutropenia (38%), thrombocytopenia (5%), and febrile neutropenia (3.8%). One patient (0.2%) died due to neutropenic infection. In Study 1, 9.4% of LONSURF‑treated patients received granulocyte‑colony stimulating factors.

Obtain complete blood counts prior to and on day 15 of each cycle of LONSURF and more frequently as clinically indicated. Withhold LONSURF for febrile neutropenia, Grade 4 neutropenia, or platelets less than 50,000/mm3. Upon recovery, resume LONSURF at a reduced dose as clinically indicated.

Embryo‑Fetal Toxicity: LONSURF can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with LONSURF.

USE IN SPECIFIC POPULATIONS

Lactation: It is not known whether LONSURF or its metabolites are present in human milk. There are no data to assess the effects of LONSURF or its metabolites on the breast‑fed infant or the effects on milk production. Because of the potential for serious adverse reactions in breast‑fed infants, advise women not to breastfeed during treatment with LONSURF and for 1 day following the final dose.

Male Contraception: Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use condoms during treatment with LONSURF and for at least 3 months after the final dose.

Geriatric Use: Patients 65 years of age or over who received LONSURF had a higher incidence of the following compared to patients younger than 65 years: Grade 3 or 4 neutropenia (48% vs 30%), Grade 3 anemia (26% vs 12%), and Grade 3 or 4 thrombocytopenia (9% vs 2%).

Hepatic Impairment: Patients with severe hepatic impairment (total bilirubin greater than 3 times ULN and any AST) were not studied. No adjustment to the starting dose of LONSURF is recommended for patients with mild hepatic impairment. Do not initiate LONSURF in patients with baseline moderate or severe (total bilirubin greater than 1.5 times ULN and any AST) hepatic impairment.

Renal Impairment: In Study 1, patients with moderate renal impairment (CLcr=30 to 59 mL/min, n=47) had a higher incidence (difference of at least 5%) of ≥Grade 3 adverse events, serious adverse events, and dose delays and reductions compared to patients with normal renal function (CLcr ≥90 mL/min, n=306) or patients with mild renal impairment (CLcr=60 to 89 mL/min, n=178).

Patients with moderate renal impairment may require dose modifications for increased toxicity. Patients with severe renal impairment were not studied.

ADVERSE REACTIONS

Most Common Adverse Drug Reactions in Patients Treated With LONSURF (≥5%): The most common adverse drug reactions in LONSURF‑treated patients vs placebo‑treated patients with refractory mCRC, respectively, were asthenia/fatigue (52% vs 35%), nausea (48% vs 24%), decreased appetite (39% vs 29%), diarrhea (32% vs 12%), vomiting (28% vs 14%), abdominal pain (21% vs 18%), pyrexia (19% vs 14%), stomatitis (8% vs 6%), dysgeusia (7% vs 2%), and alopecia (7% vs 1%).

Additional Important Adverse Drug Reactions: The following occurred more frequently in LONSURF‑treated patients compared to placebo: infections (27% vs 15%) and pulmonary emboli (2% vs 0%).

The most commonly reported infections which occurred more frequently in LONSURF‑treated patients were nasopharyngitis (4% vs 2%) and urinary tract infections (4% vs 2%).

Interstitial lung disease (0.2%), including fatalities, has been reported in clinical studies and clinical practice settings in Asia.

Laboratory Test Abnormalities in Patients Treated With LONSURF: Laboratory test abnormalities in LONSURF‑treated patients vs placebo-treated patients with refractory mCRC, respectively, were anemia (77% vs 33%), neutropenia (67% vs 1%), and thrombocytopenia (42% vs 8%).

Please see full Prescribing Information.

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